Impact of Oocyte Extract Supplement on Quality of Life after Hepatectomy for Liver Tumours: A Prospective, Multicentre, Double-Blind Randomized Clinical Trial

Cancers (Basel). 2023 May 18;15(10):2809. doi: 10.3390/cancers15102809.

Abstract

Background: Previous studies on oocyte extract supplementation showed benefits in patients with liver tumours. In this trial, we hypothesized that the oocyte extract supplement impacted the QoL after hepatectomy for hepatocellular carcinoma and intrahepatic cholangiocarcinoma.

Methods: This was a multicentre, double-blind, randomized clinical trial designed to assess the QoL of patients receiving a supplement of oocyte extract or placebo postoperatively. QoL was assessed using the Short Form-36 questionnaire in participants randomly assigned to treatment (Synchrolevels) or placebo. All study personnel and participants were masked to treatment assignment. The endpoint was the change in the QoL score.

Results: Between June 2018 and September 2022, 66 of 128 expected patients were considered as per interim analysis, of which 33 were assigned to the treatment and 33 to the placebo group. Baseline and clinicopathological characteristics were similar between the two groups. In the treatment group, the health, mental and psychological status improved for many of the items considered, reaching statistical significance, while in the placebo group, those items either did not change or were impaired in comparison with the corresponding baseline.

Conclusions: Supplementation with oocyte extract modifies QoL after liver surgery by enhancing functional recovery. Further in-depth studies are required to confirm this evidence.

Keywords: cholangiocarcinoma; hepatocellular carcinoma; liver surgery; oocyte extract; postoperative recovery; quality of life; supplementation therapy in liver surgery.

Grants and funding

This study was in part funded by Aurora Biosearch (Via IV Novembre 92, 20021 Bollate, Milan, Italy—info@aurorabiosearch.it). The funder of the study had no role in study design, data collection, data analysis, data interpretation or writing of the report. The corresponding author had final responsibility for the decision to submit for publication.